Skip to content
Recall Observatory FDA recall evidence

Device product

Posterior LITE w/ Capio SLIM; Model #M0068318150. Indicated for tissue reinforcement in women with pelvic organ prolapse.

Z-1623-2018

February 12, 2018

Class II

Product summary

Firm
Boston Scientific Corporation
Event
Event 79608
Status
Terminated
Classification
Class II
Quantity
1,541
Official record key
device-enforcement:Z-1623-2018

Official wording

Reason: Potential for Capio sutures to break and /or detach.

Code information: GTIN: 08714729854548 Batch numbers: 36893 20721161 20867461 39699 20750829 20884690 47724 20750830 20884691 49915 20750831 20884692 49916 20774546 21021770 52597 20803727 21250250 56828 20803728 21320277 58771 20803729 21351865 60410 20807399 21359456 60770 20807700 ML00003061 62154 20807701 ML00003213 62509 20830041 ML00003329 20720887 20830060 ML00003360 20720888 20830202 20720889 20865779

Distribution pattern: Worldwide Distribution -- US, Brazil, Guatemala, Ecuador, Malaysia, Czech Republic, United Kingdom, Argentina, Honduras, Peru, Singapore, Denmark, Iceland, Chile, Nicaragua, Venezuela, Japan, Egypt, Israel, Canada, Panama, Taiwan, United Arab Emirates, Finland, Ireland, Mexico, Dominican Republic, Hong Kong, Austria, France, Italy, Costa Rica, Trinidad and Tobago, Australia, Bahrain, Georgia, Islamic Republic of Iran, El Salvador, Colombia, New Zealand, Belgium, Germany, Jordan, Norway, Russia, Pakistan, Slovakia, Portugal, South Africa, Oman, Saudi Arabia, Poland, Slovenia, Qatar, Spain, Kenya, Lebanon, Mauritius, Netherlands, Sweden, Turkey, Kuwait, Malta, Namibia, Romania, Switzerland, and Greece.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential for Capio sutures to break and /or detach.